BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122509 · Received May 15, 2013

    Report

    Report Number
    2953161-2013-00069
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    October 1, 2012
    Report Date
    April 23, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC141000/03849991, PXC201000/03976054, PXC201200/03868628, AND PXC141400/828666.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK. ON (B)(6) 2011, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK REPORTEDLY DID NOT RESOLVE WITH THE IMPLANT OF THE ADDITIONAL DEVICE. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN, AND A CT SCAN AGAIN IDENTIFIED A TYPE II ENDOLEAK WITH ANEURYSM ENLARGEMENT FROM 7.5 CM TO 9 CM. IT WAS REPORTED THE TYPE II ENDOLEAK WAS ORIGINATING FROM LUMBAR ARTERIES. ON (B)(6) 2012, AN ATTEMPT WAS MADE TO TREAT THE TYPE II ENDOLEAK USING INTERVENTIONAL RADIOLOGY, BUT IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO GAIN ACCESS INTO THE ANEURYSM SAC. ON (B)(6), 2012, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY THE FIVE GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED, THROMBECTOMY OF THE ANEURYSM SAC WAS PERFORMED, AND THE ANEURYSM WAS REPAIRED WITH A SURGICAL GRAFT. THE PATIENT TOLERATED THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214673 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 03908971

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R CLINADAMYCIN| VANCOMYCIN